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KERX > SEC Filings for KERX > Form 8-K on 23-Apr-2014All Recent SEC Filings

Show all filings for KERYX BIOPHARMACEUTICALS INC

Form 8-K for KERYX BIOPHARMACEUTICALS INC


23-Apr-2014

Regulation FD Disclosure, Financial Statements and Exhibits


Item 7.01. Regulation FD

From time to time, Keryx Biopharmaceuticals, Inc. (the "Company") intends to conduct meetings with third parties in which the attached posters are presented. The posters are being presented today at the National Kidney Foundation 2014 Spring Clinical Meeting, taking place April 22-26, 2014 in Las Vegas, NV, and include the following:

"Phosphorus Binding with Ferric Citrate is Associated with Fewer Hospitalizations and Reduced Hospitalization Costs," R. Rodby, poster number 422;

"Economic Impact of Ferric Citrate Versus Standard of Care for Hemodialysis Patients," S. Brunelli, poster number 156;

"Phosphorus Binding with Ferric Citrate Reduces Erythropoiesis-Stimulating Agent (ESA) and IV Iron Usage and Cost in Patients with ESRD," R. Rodby, poster number 415; and

"Zerenex (Ferric Citrate Coordination Complex) for the Treatment of Iron-Deficiency Anemia and Reduction of Serum Phosphate in Non-Dialysis Dependent CKD," G. Block, poster number 423.

Copies of these posters are attached as Exhibits 99.1, 99.2, 99.3 and 99.4, respectively, to this Current Report on Form 8-K and the information contained therein is incorporated herein by reference.

The information in this Item 7.01 and Exhibits 99.1, 99.2, 99.3 and 99.4 shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act") or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.



Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

The Company hereby furnishes the following exhibits:

Exhibit
Number                                    Description

99.1         "Phosphorus Binding with Ferric Citrate is Associated with Fewer
             Hospitalizations and Reduced Hospitalization Costs," R. Rodby, poster
             number 422.

99.2         "Economic Impact of Ferric Citrate Versus Standard of Care for
             Hemodialysis Patients," S. Brunelli, poster number 156

99.3         "Phosphorus Binding with Ferric Citrate Reduces
             Erythropoiesis-Stimulating Agent (ESA) and IV Iron Usage and Cost in
             Patients with ESRD," R. Rodby, poster number 415.

99.4         "Zerenex (Ferric Citrate Coordination Complex) for the Treatment of
             Iron-Deficiency Anemia and Reduction of Serum Phosphate in
             Non-Dialysis Dependent CKD," G. Block, poster number 423.

Forward-looking Statements

Some of the statements included in this Form 8-K and the exhibit attached hereto, particularly those relating to the results of clinical trials, the clinical benefits to be derived from Zerenex (ferric citrate coordination complex), regulatory submissions and approvals, the commercial opportunity and competitive positioning, and any business prospects for Zerenex, may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: the risk that the FDA PDUFA goal date for our Zerenex NDA is subject to change and does not guarantee that the review of the NDA will be completed on a timely basis; the risk that the FDA, and/or EMA ultimately deny approval of the U.S. NDA, and/or MAA, respectively; the risk that SPAs are not a guarantee that the FDA will ultimately approve a product candidate following filing acceptance; whether the FDA and EMA will concur with our interpretation of our Phase 3 study results, supportive data, or the conduct of the studies; whether, Zerenex, if approved by the FDA and/or EMA, will be successfully launched and marketed; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this Form 8-K and the exhibit attached hereto speak only as of the date of this report. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.


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